Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study

Wheeler, Cosette M.; Skinner, S. Rachel; Rosario-Raymundo, Maria Rowena Del; Garland, Suzanne M.; Chatterjee, Archana; Lazcano‐Ponce, Eduardo; Salmerón, Jorge; McNeil, Shelly; Stapleton, Jack T.; Bouchard, Céline; Martens, Mark G.; Money, Deborah; Quek, Swee Chong; Romanowski, Barbara; Vallejos, Carlos S.; Harmsel, Bram ter; Prilepskaya, Prilepskaya V.N.; Fong, Kah Leng; Kitchener, Henry C; Minkina, Galina; Lim, Yong Kuei; Stoney, Tanya; Chakhtoura, Nahida; Cruickshank, Margaret; Savicheva, Alevtina; Silva, Daniel Pereira da; Ferguson, Murdo; Molijn, Anco; Quint, Wim; Hardt, Karin; Descamps, Dominique; Suryakiran, P.V.; Karkada, Naveen; Geeraerts, Brecht; Dubin, Gary; Struyf, Frank

doi:10.1016/s1473-3099(16)30120-7

Cited by 160 publications

(132 citation statements)

References 35 publications

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“…Second, 7-year follow-up data of Vaccine Immunogenicity and Efficacy (VIVIANE) study [40], a phase III, double-blind, randomized controlled trial of HPV 16/18 vaccine in women >25 years, were reported in The Lancet Infectious Diseases in 2016 [41]. In this study, a total of 5,747 women was in the vaccinated cohort (n=2,877 vaccine and n=2,870 control) and 4,407 were in the according-to-protocol cohort for efficacy (n=2,209 vaccine and n=2,198 control).…”

Section: Cervical Cancermentioning

confidence: 99%

Major clinical research advances in gynecologic cancer in 2016: 10-year special edition

Suh

Kim

et al. 2017

J Gynecol Oncol

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In 2016, 13 topics were selected as major research advances in gynecologic oncology. For ovarian cancer, study results supporting previous ones regarding surgical preventive strategies were reported. There were several targeted agents that showed comparable responses in phase III trials, including niraparib, cediranib, and nintedanib. On the contrary to our expectations, dose-dense weekly chemotherapy regimen failed to prove superior survival outcomes compared with conventional triweekly regimen. Single-agent non-platinum treatment to prolong platinum-free-interval in patients with recurrent, partially platinum-sensitive ovarian cancer did not improve and even worsened overall survival (OS). For cervical cancer, we reviewed robust evidences of larger-scaled population-based study and cost-effectiveness of nonavalent vaccine for expanding human papillomavirus (HPV) vaccine coverage. Standard of care treatment of locally advanced cervical cancer (LACC) was briefly reviewed. For uterine corpus cancer, new findings about appropriate surgical wait time from diagnosis to surgery were reported. Advantages of minimally invasive surgery over conventional laparotomy were reconfirmed. There were 5 new gene regions that increase the risk of developing endometrial cancer. Regarding radiation therapy, Post-Operative Radiation Therapy in Endometrial Cancer (PORTEC)-3 quality of life (QOL) data were released and higher local control rate of image-guided adaptive brachytherapy was reported in LACC. In addition, 4 general oncology topics followed: chemotherapy at the end-of-life, immunotherapy with reengineering T-cells, actualization of precision medicine, and artificial intelligence (AI) to make personalized cancer therapy real. For breast cancer, adaptively randomized trials, extending aromatase inhibitor therapy, and ribociclib and palbociclib were introduced.

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Section: Cervical Cancermentioning

confidence: 99%

Major clinical research advances in gynecologic cancer in 2016: 10-year special edition

Suh

Kim

et al. 2017

J Gynecol Oncol

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“…However, current data reveals high rates of immunogenicity and adequate duration of protection without any need for a booster dose. The 7-year follow-up of the VIVIANE study revealed that HPV 16-18 vaccine is still successful in protecting women older than 25 years against infections, cytological abnormalities, and lesions associated with HPV 16-18 as well as HPV 31 and HPV 45 (20).…”

Section: Efficacy and Safetymentioning

confidence: 99%

HPV Vaccines: Current Status

Sarı¹,

Meydanlı²

2017

Gynecol Obstet Reprod Med

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Cervical cancer is the fourth most common cancer in women worldwide, and the main cause is Human Papillomavirus infection. Human Papillomavirus vaccines have had dramatic impacts on the prevalence of targeted Human Papillomavirus types (6,11,16 and 18), genital warts and precancerous cervical lesions. The World Health Organization and Centers for Disease Control and Prevention have confirmed the safety of Human Papillomavirus vaccines after >250 million doses were administered worldwide. World Health Organization approved the two-dose-schedule of Human Papillomavirus vaccines in females younger than 15 years of age, with ≥6 month intervals. Extension of vaccination to men could further reduce the population prevalence of Human Papillomavirus and provide direct protection of men against genital warts and anal, penile and oropharyngeal cancers. Txhe nine-valent Human Papillomavirus vaccine has demonstrated equivalent protection against the four types in the quadrivalent vaccine and high efficacy against the next five commonest causes of cervical cancer (Human Papillomavirus types 31,33,45,52 and 58). The Advisory Committee on Immunization Practices recommends the nine-valent vaccine and it has been approved by the FDA in 2014 for both genders between 11-12 years of age.

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“…The HPV‐FASTER protocol, as proposed by an international group including many European countries, Australia and Mexico, aims to address this disconnection by combining both strategies with the ultimate purpose of accelerating the reduction in cervical cancer incidence and related mortality. Their proposal is based on the consistent results of previously describe primary HPV screening trials as well as with results from phase III trials comparing HPV vaccination against placebo among adult women (up to 55 years of age) . Their proposal includes HPV vaccination to women in a broad age range of 9–45 years, irrespective of HPV status and HPV‐based screening.…”

Section: Introductionmentioning

confidence: 98%

Cervical cancer screening in the era of HPV vaccination: A review of shifting paradigms in cytopathology

Barroeta

Adhikari-Guragain

Grotkowski

2017

Diagnostic Cytopathology

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Significant changes in cervical cancer screening practice, guidelines, and prevention of cervical cancer have taken place in recent years including the raising of initial cervical cancer screening age, changes in frequency of cytology screening, and the adoption of high risk HPV and cytology co-testing for some patients; the introduction of the bivalent, quadrivalent, and 9-valent HPV vaccines; and the recent approval of high risk HPV testing as primary screening with the use of cytology as triage in positive cases. This review discusses the significance of primary HPV screening, the impact of HPV vaccination in the prevalence of cervical cancer and its precursors, the interplay between high risk HPV testing and vaccination, and the implications for clinical and cytological management. Future strategies for cervical screening in the post-vaccination era are also discussed.

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Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study

Abstract: GlaxoSmithKline Biologicals SA.

Cited by 160 publications

References 35 publications

Major clinical research advances in gynecologic cancer in 2016: 10-year special edition

Major clinical research advances in gynecologic cancer in 2016: 10-year special edition

HPV Vaccines: Current Status

Cervical cancer screening in the era of HPV vaccination: A review of shifting paradigms in cytopathology

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